The efficacy and safety of remimazolam versus propofol on emergence agitation in children undergoing root canal therapy when combined with sevoflurane: a randomized controlled trial

Introduction

Background

Dental general anesthesia (DGA) is a behavioral management technique that involves rendering children unconscious. Patient safety is ensured through airway inspection and facilitate oral treatment under close supervision (1). General anesthesia can alleviate children’s anxiety and pain, thereby saving time for both parents and clinicians (2). However, the process of general anesthesia is associated with a range of complications, with postoperative agitation being one of the common issues.

Rationale and knowledge gap

Emergence agitation (EA) is a frequent early postoperative adverse behavior with an incidence ranging from 20% to 50%. It typically begins around 15 minutes after extubation, with a higher prevalence in children compared to adults. The highest incidence of EA occurs in children aged 2 to 5 years, while it is lower in the elderly (3,4). EA in children during the recovery period refers to a transient disturbance in consciousness and perception caused by anesthesia, resulting in inconsolable crying and restless movements of the hands and feet. In severe cases, children may even remove catheters, urinary catheters, and endotracheal tubes (5). Outpatient anesthesia differs from in-hospital anesthesia due to less frequent contact with anesthesiologists, lower awareness of anesthesia risks, a lack of monitoring equipment, and insufficient consideration of anesthesia needs during the design of many procedures. Limited space and the inconvenience of anesthesiologist operations, along with difficulties in obtaining medications and equipment in emergencies, add to the complexity. Anesthesia management for outpatient procedures requires rapid, stable, quick recovery, and minimal postoperative complications. Agitation not only increases heart rate (HR) and oxygen consumption in children but may also lead to accidental injuries and even threaten life (6). Additionally, the increased restlessness, crying, and emotional distress in children exacerbate anxiety for parents and medical staff, negatively impacting postoperative recovery, which contradicts the principles of comfort care and accelerated recovery.

Sevoflurane is commonly administered to induce general anesthesia, mainly because of its rapid onset and recovery from, and lack of airway irritation, making it especially suitable for uncooperative children during oral treatments (7). Inhalational sevoflurane anesthesia helps establish venous access and ensures security for subsequent diagnosis and treatment. However, the high incidence of agitation during the recovery phase of general anesthesia can impact postoperative recovery (8). Research has found that the use of combined intravenous and inhalational anesthesia reduces the incidence of agitation during emergence (9). Propofol is the most commonly used intravenous anesthetic because it produces a rapid onset in anesthesia and has a brief duration of action. Costi et al. continued to use 3 mg/kg propofol for 3 min in 230 children with magnetic resonance imaging (MRI) under sevoflurane anesthesia aged 1 to 12 years, the incidence, duration, and severity of agitation were also significantly reduced, and the discharge time of the children was not prolonged (10). However, it is associated with significant injection pain and considerable effects on respiratory and circulatory systems. Adverse effects such as injection pain, allergic reactions, mitochondrial diseases, and propofol-related infusion syndrome (PRIS) limit its use in pediatric patients (11,12). Children induced with propofol may face severe hypoxemia risks. In contrast, remimazolam is metabolized by carboxylesterase 1 (CES1), with organ-independent clearance and the potential for specific reversal by flumazenil, offering theoretical advantages for outpatient dental management (13,14). Although remimazolam has been studied in laparoscopic surgery, its specific synergy with sevoflurane in the context of relatively painless but high-anxiety dental procedures remains significant knowledge gaps, and this study aims to fill these gaps (15). However, the effect of combining remimazolam with sevoflurane on EA in children undergoing root canal therapy (RCT) has not been clearly established.

Objective

Our study aims to explore the impact of remimazolam on EA in children undergoing RCT, hypothesizing that remimazolam can reduce the incidence of EA and may be more suitable than propofol for pediatric RCT. We present this article in accordance with the CONSORT reporting checklist (available at https://joma.amegroups.com/article/view/10.21037/joma-2026-0010/rc).

Methods

Patient selection

Between April 2023 and April 2024, patients aged 2 to 7 years with American Society of Anesthesiologists (ASA) physical statuses of 1 or 2, scheduled for RCT in The First Affiliated Hospital of Zhengzhou University were screened for eligibility. Exclusion criteria included congenital heart disease (e.g., patent ductus arteriosus, tetralogy of Fallot, ventricular septal defect, etc.), respiratory diseases (such as upper respiratory tract infections, lung infections, bronchial asthma, etc., occurring within the last 2 weeks), rhinitis or nasal deformities, intellectual disabilities, and other psychiatric disorders (such as mania, schizophrenia, mental disorders, and cognitive dysfunction), as well as allergies to remimazolam, propofol, and opioids. After patients provided written informed consent and who met the eligibility criteria were enrolled. Patients were allocated at random into two groups, namely a remimazolam group and a propofol group. Randomization was conducted using the random number table method. Allocation concealment was achieved using sequentially numbered, opaque, sealed envelopes prepared by an independent investigator. Group assignments were revealed only after the child was in the operating room. Due to differences in color and infusion methods between propofol and remimazolam, the anesthesiologists could not be blinded. Another investigator, a trained independent nurse from the post-anesthesia care unit (PACU), who was completely blinded to the group assignments, supervised the emergence and recovery process, including assessment of EA. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study protocol was approved by the Ethics Committee of The First Affiliated Hospital of Zhengzhou University (approval No. 2023-KY-0330-003; principal investigator: N.X.). This randomized controlled trial was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2300075012). Written informed consent was obtained from the parents. The parents affirm that they provided informed consent for publication of the data.

Study protocol

Before the operation, the children were forbidden to consume clear liquids for 2 hours, breast milk for 4 hours, infant formula and milk for 6 hours, easily digestible starch solid food for 6 hours, and non-digestible high-protein and high-fat food for 8 hours. Upon entering the operating room, blood pressure, HR, pulse oximetry, the electrocardiogram (ECG), and partial pressure of end-respiratory carbon dioxide were monitored. Induction of anesthesia includes behavioral methods such as using a balloon (8% sevoflurane), followed by the establishment of an intravenous line. In the remimazolam group, remimazolam (0.2 mg/kg), remifentanil (0.5 to 1 µg/kg), and cisatracurium (0.1 to 0.15 mg/kg) were administered intravenously. In the control group, propofol (1.5 to 2 mg/kg) was administered intravenously, with the administration of remifentanol and cisatracurium being the same as in the remimazolam group. During maintenance of anesthesia, 0.5 to 1 mg/kg of remimazolam and 0.05 to 1 µg/kg/min remifentanil via intravenous pump. The control group receives 4 to 6 mg/kg of propofol and 0.05 to 1 µg/kg/min remifentanil via the same method. Both were compounded with sevoflurane 1.5%, maintaining the BIS near 50 (range, 40 to 60) in both groups. During surgery, the operating room temperature was maintained at approximately 25 ℃. At the end of the surgery, all medication was stopped straightaway. The patient was extubated once regular spontaneous breathing and airway reflexes were clearly restored and then transferred to PACU for continuous anesthesia monitoring.

Study outcomes

The rate of occurrence of EA was the primary outcome. The assessment of EA is primarily conducted using pediatric anesthesia emergence delirium (PAED) and Aono scales. The PAED scale includes 5 psychological items, with a score range of 0 to 20. A PAED score of 12 or above is diagnosed as EA. The Aono scale ranges from 1 to 4, where 1 indicates calm; 2 indicates anxious but consolable; 3 indicates difficult to calm or moderate agitation; and 4 indicates excited, confused, or agitated. In the PACU, a single trained study member, blinded to the group allocations, was responsible for documenting the PAED score and Aono score at 0, 5, 10, 20, and 30 min after emergence from anesthesia. Additionally, if any signs suggestive of emergence delirium appeared during these intervals, immediate assessments using the PAED and Aono scales were conducted.

Secondary outcomes include the incidence of intraoperative bradycardia (HR <60 beats per minute), tachycardia (HR >120 beats per minute), and hypotension (less than 20% of baseline systolic or mean arterial pressure), as well as extubation time (time from drug withdrawal to tracheal extubation) and full awakening time [time from drug withdrawal to Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) reaching 5 points]. Additionally, PACU discharge time (time from admission to the PACU to achieving a modified Aldrete score of 10), the incidence of adverse reactions from anesthesia until PACU discharge, and the evaluation of family satisfaction are also measured. All adverse events were continuously monitored from the start of anesthesia until PACU discharge by a dedicated, blinded PACU nurse using a standardized checklist, rather than recorded only when they occurred.

Sample size

The sample size calculation was based on the incidence of EA in the observation and control groups. Combining previous study results and preliminary experiments, the incidence of agitation with remimazolam combined with sevoflurane was about 25%, while the incidence of sedation agitation with propofol combined with sevoflurane was about 50%. Assuming a sample ratio of 1:1, a significance level of 0.05, and a power of 80%, 55 study patients were required. Assuming an attrition rate of 15%, 63 children were included in each group (126 patients in total).

Statistical analysis

Statistical analyses were carried out using GraphPad Prism software. Continuous data that were normally distributed are given as the mean ± standard deviation (SD), and non-normally distributed data are shown as the median and interquartile range (IQR). Categorical data are presented as counts and percentages. Age, height, weight, body mass index, PAED score, Aono score, and profiles of recovery in the postoperative period were compared using the t-test (normally distributed data) or the Wilcoxon rank-sum test (non-normally distributed data). Sex, ASA physical status, history of general anesthesia, the incidence of EA, and the adverse reactions in the two groups were analyzed using the Chi-squared or Fisher’s exact tests. A P value <0.05 was deemed to be a statistically significant result.

Results

Of 132 patients, 6 patients were excluded due to refusal to participate or changes in their operation schedules, and 126 were included in the randomization (see Figure 1). Two patients from each group were excluded because they did not receive the allocated intervention or did not complete the case assessment. Thus, data from 122 patients were included in the final analyses. The baseline characteristics were similar in both groups of patients (Table 1).

Figure 1 Flowchart of the study procedure.

Overall, the rate of occurrence of EA was 30.33% (37/122). Compared to the control group, the rate of EA was less in the remimazolam group [{12 out of 61 cases in the control group, accounting for 19.67% vs. 25 out of 61 cases, accounting for 40.98%; relative risk [95% confidence interval (CI)]: 0.48 (0.26–0.84), P=0.01; see Table 2}. To address missing data and preserve the integrity of randomization, we performed an intention-to-treat (ITT) analysis using multiple imputation for the four excluded patients (two per group). The ITT analysis confirmed that remimazolam significantly reduced the incidence of EA compared with propofol [19.05% vs. 41.27%; relative risk (95% CI): 0.46 (0.25–0.81), P=0.007; see Table S1], consistent with the per-protocol analysis. The PAED score {6 [3–9.5] vs. 8 [6–13], P=0.002; see Table 2} was also lower in the remimazolam group.

The time to extubation was 14 [10–16] min in the control group and 13 [10–15.5] min in the remimazolam group (P=0.71). The time to full awakening was 30 [22.5–35.5] min in the control group and 37 [30–44] min in the remimazolam group (P<0.001). The time to leave the PACU was 60 [49–62.5] min in the control group and 56 [50–60] min in the remimazolam group (P=0.74). Parent satisfaction scores were 9 [8–10] in the control group and 10 [9–10] in the remimazolam group (P=0.03; Table 3).

The incidence of intraoperative bradycardia, tachycardia, and hypotension did not differ significantly (Table 4).

Discussion

Key findings

Remimazolam is an ultra-short-acting benzodiazepine with sedative and hypnotic effects. Its efficacy and safety in general anesthesia have been shown to be comparable to propofol, but there is limited research on its use in children with EA (16,17). In the present trial, the efficacy and actions of remimazolam in pediatric elective dental surgery were comprehensively evaluated. First, regarding the impact on agitation during recovery, the results revealed that the incidence of postoperative agitation in the remimazolam group was significantly less than in the propofol group when used in combination with sevoflurane, indicating that remimazolam has certain advantages in pediatric dental surgery conducted under general anesthesia. Second, no significant adverse reactions were found with the use of remimazolam in pediatric elective surgery patients, suggesting that remimazolam is relatively safe for use in pediatric general anesthesia. Additionally, in terms of efficacy, the results indicated that remimazolam tosylate provides good induction and maintenance of general anesthesia, effectively bringing patients into an anesthetic state and maintaining satisfactory sedation. However, it did not show advantages in shortening recovery time or reducing postoperative recovery time. Although the trial results indicate the potential advantages of remimazolam in pediatric elective dental surgery under general anesthesia, this does not imply that it is suitable for all patients. Individual assessments should be made based on the specific conditions of each patient.

Explanations of findings

Regarding the assessment of EA, various evaluation schemes have been developed, including the Watcha score, Aono score, and the five-step scoring system, PAED scale, etc. The PAED scale is the most commonly used objective scoring system for postoperative agitation in children. Some researchers have defined a PAED score of ≥16 as indicative of agitation, while more recent studies have used a PAED score of ≥12. Since most assessment methods are subjective, this study also employed the Aono scoring scale to complement the evaluation of EA. Nevertheless, the median Aono score was identical in both groups. However, statistically significant differences still emerged due to the disparate distribution and dispersion patterns within the two data sets.

There are conflicting conclusions regarding the impact of benzodiazepines on EA. Munk et al. avoided using benzodiazepines in their study, which found that the rate of occurrence of EA was significantly less compared to similar studies (18). Duan et al. found that remimazolam, compared to propofol, reduced the incidence of EA in elderly patients who underwent hip replacement surgery (19). Cai et al. found that during combined sevoflurane anesthesia, both continuous infusion and single infusion of remazolam can effectively reduce the incidence of delirium during the recovery period of children undergoing laparoscopic surgery, with stable hemodynamics and few adverse reactions (15). In this study, we observed that in children undergoing RCT, the incidence of EA was significantly reduced when remimazolam was used in combination with sevoflurane. This effect may be related to its mechanism. Remimazolam has sedative, analgesic, and hypnotic properties, which work by modulating neurotransmitter activity to reduce central nervous system excitability, thereby alleviating patient anxiety and promoting a smoother recovery process. By inhibiting neural transmission and reducing pain perception, it helps to decrease the severity of pain and improve the quality of recovery (20-22).

Comparison with similar research

Previous studies have indicated that remimazolam can prolong the extubation time (19). In our trial, no difference in extubation times between the remimazolam and propofol groups were found, primarily because we chose to extubate the children after they had recovered spontaneous breathing but before full consciousness. Our study found that the time to being fully awake were longer in the remimazolam group, which is consistent with previous research (16). No significant difference in PACU discharge times between the control and remimazolam groups were detected. However, the remimazolam group had higher family satisfaction, which may be primarily due to the lower incidence of agitation during recovery in the remimazolam group.

Cardiovascular complications such as hypoxemia, hypotension, and arrhythmias are known to contribute to agitation during the recovery from general anesthesia. Therefore, maintaining hemodynamic stability is crucial. In this study, although remimazolam significantly reduced the incidence of agitation during recovery, there were no significant differences in the rates of intraoperative hypotension, bradycardia, or tachycardia between the two groups. This may be because, despite the low incidence of cardiovascular complications in both groups, the remimazolam group maintained better cardiovascular stability throughout the surgery (23). It is worth noting that there was one case of intraoperative body movement in the remimazolam group, but it did not affect the surgery or cause adverse reactions to the patient. The safety of remimazolam for induction and maintenance of anesthesia was comparable to that of propofol.

Strengths and limitations

The restlessness during the postoperative recovery period of children has a significant negative impact on their recovery. It is very necessary to find more comfortable and safe drugs. In this study, the incidence of restlessness in the remimazolam group decreased significantly.

Our trial had a number of limitations. First, patients younger than 2 years old were not included. Age is a critical risk factors for EA, and younger patients are significantly affected. We excluded those under 2 years old because clinical dental treatments typically involve patients older than 2 years. Second, we did not perform postoperative follow-up, so it is unclear whether the reduction in agitation with remimazolam improves postoperative recovery quality. Further well-designed clinical trials are needed to analyze the relationship between remimazolam and postoperative recovery quality. Third, we did not investigate preoperative anxiety and postoperative pain. Preoperative anxiety and postoperative pain are risk factors for EA, as pain stimulation is a major factor inducing agitation in children during recovery. Fourth, due to the different color and infusion method of remimazolam versus propofol, the anesthesiologist could not be blinded. A double-dummy design was considered but rejected to avoid two separate intravenous lines or sequential infusions, which would increase distress in young children. This may introduce performance bias in intraoperative anesthetic management; however, the outcome assessor remained blinded, and EA was assessed by a blinded investigator. Also, we did not analyze the relationship between preoperative anxiety, postoperative pain, and EA.

Implications and actions needed

Due to their age, children have lower pain tolerance and may exhibit symptoms such as crying and trembling with even mild pain, which can be exacerbated by localized pain around the surgical site. Further prospective research is needed to confirm the efficacy in children under the age of 2 years.

Conclusions

In summary, when combined with sevoflurane, the simultaneous administration of remimazolam significantly reduced the incidence of EA in children undergoing RCT compared with propofol and can be considered a suitable agent for inducing general anesthesia in pediatric patients.

Acknowledgments

The authors appreciate the staff in the operating room and PACU for their assistance during data collection. No part of this manuscript has been presented elsewhere. During the preparation of this work, the authors used AI only for language polishing and grammar checking. No AI tools were used for data analysis, interpretation, or manuscript writing. The authors take full responsibility for the content.

Footnote

Reporting Checklist: The authors have completed the CONSORT reporting checklist. Available at https://joma.amegroups.com/article/view/10.21037/joma-2026-0010/rc

Trial Protocol: Available at https://joma.amegroups.com/article/view/10.21037/joma-2026-0010/tp

Peer Review File: Available at https://joma.amegroups.com/article/view/10.21037/joma-2026-0010/prf

Funding: This work was supported by “the Three 100” Plan for the Training of Clinical Research-Oriented Physicians (No. HNCRD202427) and the Henan Province Health Young and Middle Age Discipline Leader Training Project (No. HNSWJW-2022023).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://joma.amegroups.com/article/view/10.21037/joma-2026-0010/coif). H.J. serves as an Editor-in-Chief of Journal of Oral and Maxillofacial Anesthesia. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study protocol was approved by the Ethics Committee of The First Affiliated Hospital of Zhengzhou University (approval No. 2023-KY-0330-003; principal investigator: N.X.). This randomized controlled trial was prospectively registered with the Chinese Clinical Trial Registry (ChiCTR2300075012). Written informed consent was obtained from the parents. The parents affirm that they provided informed consent for publication of the data.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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